Completed

Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Hematologic Diseases

+ Hemic and Lymphatic Diseases

+ Anemia

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2011
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: July 5, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 30, 2011

Actual date on which the first participant was enrolled.

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

NCT01677767
Principal SponsorHoffmann-La Roche
Last updated: July 5, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

127 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesAnemia

Criteria

4 inclusion criteria required to participate
Adequate irons status as judged by the treating physician
Adult patients, 18 to 65 years of age, inclusive
ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
Patients with chronic kidney disease on dialysis
7 exclusion criteria prevent from participating
Clinical suspicion of pure red cell aplasia (PRCA)
Clinically significant concomitant disease or disorder as defined by protocol
Contraindications for Mircera according to local prescribing information or as judged by the investigator
Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Sir Gangaram Hospital

New Delhi, IndiaOpen Sir Gangaram Hospital in Google Maps

Ahmedabad Dialysis Centre

Ahmedabad, India

Excel Center

Guwahati, India

ESIS Hospital; Department of Nephrology

Kolkata, India
Completed7 Study Centers